of this title, the term of each of the following patents shall be extended in accordance with this section:
(1) Any patent which encompasses within its scope a composition of matter which is a new drug product, if during the regulatory review of the product by the Federal Food and Drug Administration
(A) the Federal Food and Drug Administration notified the patentee, by letter dated February 20, 1976, that such products new drug application was not approvable under section 505(b)(1) of the Federal Food, Drug and Cosmetic Act;
(B) in 1977 the patentee submitted to the Federal Food and Drug Administration the results of a health effects test to evaluate the carcinogenic potential of such product;
(C) the Federal Food and Drug Administration approved, by letter dated December 18, 1979, the new drug application for such product; and
(D) the Federal Food and Drug Administration approved, by letter dated May 26, 1981, a supplementary application covering the facility for the production of such product.
